BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXXAIR ETS MRS

    MDR report key: 1272283 · Received December 19, 2008

    Report

    Report Number
    1625774-2008-00065
    Event Type
    Death
    Date Received
    December 19, 2008
    Date of Event
    September 22, 2008
    Report Date
    November 24, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO A REPRESENTATIVE FROM THE MEDICAL CENTER, THE PATIENT HAD A HISTORY OF ATTEMPTING TO EXIT THE BED ON HER OWN. THE REPRESENTATIVE DESCRIBED THE MENTAL STATUS OF THE PATIENT AS CONFUSED, RESTLESS AND ANXIOUS AND STATED THAT THE PATIENT HAD A HISTORY OF NON-COMPLIANCE. ACCORDING TO THE MEDICAL CENTER REPRESENTATIVE, THE HOSPITAL HAS A POLICY AGAINST LEAVING ALL FOUR OF THE BED'S SIDE RAILS IN THE UP POSITION, AS THIS IS CONSIDERED A RESTRAINT BY THE FACILITY. THEREFORE, THE REPRESENTATIVE REPORTED THAT ONE OF THE LOWER SIDE RAILS WAS LEFT IN THE DOWN POSITION PRIOR TO THE ALLEGED INCIDENT. NO RESTRAINTS WERE USED WITH THE PATIENT. IT WAS REPORTED THAT THE MAXXAIR ETS MRS WAS PLACED ONTO A NON-KCI BED FRAME; HOWEVER, MAXXAIR ETS MRS LABELING CAUTIONS, "WHETHER AND HOW TO USE SIDE RAILS IS A DECISION THAT SHOULD BE BASED ON EACH PATIENT'S NEEDS AND SHOULD BE MADE BY THE PATIENT AND THE PATIENT'S FAMILY, PHYSICIAN AND CAREGIVERS, WITH FACILITY PROTOCOLS IN MIND. CAREGIVERS SHOULD ASSESS RISKS AND BENEFITS OF BED RAIL/RESTRAINT USE (INCLUDING, ENTRAPMENT AND PATIENT FALLS FROM BED) IN CONJUNCTION WITH INDIVIDUAL PATIENT NEEDS, AND SHOULD DISCUSS USE OR NON-USE WITH PATIENT AND/OR FAMILY. CONSIDER NOT ONLY THE CLINICAL AND OTHER NEEDS OF THE PATIENT BUT ALSO THE RISKS OF DEATH OR SERIOUS INJURY FROM FALLING OUT OF BED AND FROM PATIENT ENTRAPMENT IN OR AROUND THE SIDE RAILS, RESTRAINS OR OTHER ACCESSORIES." THE UNIT WAS RETURNED TO THE KCI SERVICE CENTER AND TESTED PER QUALITY CONTROL PROCEDURES. THE UNIT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON A MAXXAIR ETS MRS ALLEGEDLY EXITED FROM THE BED AND OCCLUDED HER TRACHEOSTOMY TUBE. THE PATIENT WAS ALLEGEDLY FOUND UNRESPONSIVE AND IN ASYSTOLE. THE PATIENT HAD A STATUS OF "DO NOT ATTEMPT RESUSCITATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXAIR ETS MRS THERAPEUTIC, EXPANDABLE TURNING SURFACE IOQ KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death RISPERDAL| OXYCODONE (PRN)| COLACE| NPH| ALBUTEROL| METHODONE| METHACARBONAL| PARIDEX| OXIPARIN| INSULIN| ZINC| VENLAFAXINE| DAKINS| SENNA| AMPICILLIN